High Potency API Specialist

6 days ago


Dublin, Dublin City, Ireland CPL Full time

Job Description

The successful candidate will work closely with a team of R&D chemists to develop and scale up projects in the laboratory, including process development, crystallisation isolation, and process safety assessments.

Key Responsibilities:

  • Develop and implement GMP kilo lab processes for high potency active pharmaceutical ingredients (HPAPI)
  • Create Master Batch records for kilo scale materials
  • Collaborate with R&D chemists to ensure smooth transition of laboratory operations to the kilo lab facility
  • Ensure equipment qualification and readiness for batch manufacture
  • Contribute to the development and implementation of new technologies in the GMP kilo lab facility
  • Run Kilo lab scale GMP manufacture in the GMP kilo lab
  • Work cross-functionally to ensure project documentation and campaign readiness activities are completed on time
  • Collaborate with customers on development projects to ensure final process meets their expectations

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